Clinical trial · Interventional
Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer
Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate, Indomethacin and Recombinant Human Interferon-Gamma in Advanced Colorectal Cancer
NCT00002796CI-TRIAL-00009261terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon-gamma may interfere with the growth of tumor cells and slow the growth of the tumor. Combining more than one drug with interferon-gamma may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of giving fluorouracil together with phenylbutyrate, indomethacin, and interferon-gamma and to see how well it works in treating patients with stage IV colorectal cancer
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucinous Adenocarcinoma of the Colon | Colon Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Mucinous Adenocarcinoma of the Rectum | Rectal Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Signet Ring Adenocarcinoma of the Colon | — | UNRESOLVED | — |
| Signet Ring Adenocarcinoma of the Rectum | Rectal Signet Ring Cell Adenocarcinoma | ALIAS | 0.90 |
| Stage IVA Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| indomethacin | Drug | — | UNRESOLVED |
| recombinant interferon gamma | Biological | — | UNRESOLVED |
| sodium phenylbutyrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (fluorouracil, phenylbutyrate, indomethacin, IFN-G
- description
- Phase I: Patients receive 5-FU IV over 24 hours on day 1; phenylbutyrate IV over 120 hours and oral indomethacin daily on days 2-6; and interferon gamma subcutaneously on days 2, 4, and 6. Courses repeat weekly in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which less than 2 of 6 patients experience dose-limiting toxicity (DLT). Phase II: Patients receive 5-FU, phenylbutyrate, indomethacin, and interferon gamma as in phase I at the MTD.
- interventionNames
- Drug: fluorouracil
- Drug: sodium phenylbutyrate
- Drug: indomethacin
- Biological: recombinant interferon gamma
Primary outcomes (2)
- measure
- Toxicity of flurouracil (FU) when given in escalating doses in combination with fixed doses of phenlylbutyrate (PB), indomethacin and recombinant human interferon-gamma (rhIFNg) to patients with advanced colorectal cancer (Phase I)
- timeFrame
- 1 week
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Stage IV colorectal adenocarcinoma, excluding brain metastases * Histological confirmation of colorectal adenocarcinoma * Previously untreated patients * Previously treated patients * For the Phase I trial, no limitations * For the Phase II trial, previous treated limited to adjuvant radiation and/or chemotherapy which is completed at least 12 months before documentation of metastatic disease; patients may not have received chemotherapy for metastatic disease * For the Phase I trial, patients may have measurable disease or unmeasurable disease; for the Phase II trial, patients must have measurable disease in at least two dimensions on x-rays, CT scan or MRI * Expected survival of at least 16 weeks * Performance status of \>= 70% (Karnofsky) * WBC \>= 3000 uL * Platelet count \>= 100,000/uL * Bilirubin =\< 2 x ULN * Creatinine =\< 2 x ULN * Not pregnant and not lactating; women of child bearing age must have negative pregnancy test (beta-hcg) * No allergies to interferon-gamma or E.coli derived products * No serious medical intercurrent medical illnesses, including Class III or IV cardiovascular disease; patient may not be dependent on immunosuppressive drugs including corticosteroids, and may not receive these drugs for the entire duration of the study * No diarrhea, and with adequate oral intake * Patients of child-bearing age and potential must agree to use adequate birth control other than oral contraceptives for the entire duration of the study * No previous or concurrent malignancy except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, grade 1 bladder cancer, or other cancers if the patient has been disease free for \>= 5 years * Patients must be oriented and rational, and aware of the investigational nature of the study
References
Publications (0)
Data not yet available
No reference posted for this study.